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NCT00543439 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating Prophylaxis Treatment & Characterizing Efficacy, Safety, & PK Of B-Domain Deleted Recombinant FVIII
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 66
- Enrollment target
NCT00543439: Completed Phase 3 study, sponsored by Pfizer.
NCT00543439 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 66 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00543439, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 66 participants
- Enrollment target
Study Summary
The purpose of this research study is to determine the effectiveness, safety, and pharmacokinetics (PK) of moroctocog alfa (AF-CC) in previously treated subjects, who are younger than 6 years of age, with severe or moderately severe hemophilia A.
Primary Outcome
ABR for each participant was calculated as the number of bleeds requiring administration of moroctocog alfa (AF-CC) divided by the total therapy duration (in days), then multiplied by 365.25 (days in a year).
Interventions
- BIOLOGICAL Moroctocog alfa (AF-CC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2007-12 |
| Est. Completion | 2018-04 |
| Phase | Phase 3 |
What the finished NCT00543439 record still lists
NCT00543439 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which Moroctocog alfa (AF-CC) is the first listed.
NCT00543439 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00543439 about?
NCT00543439 is a clinical study titled "Study Evaluating Prophylaxis Treatment & Characterizing Efficacy, Safety, & PK Of B-Domain Deleted Recombinant FVIII". The purpose of this research study is to determine the effectiveness, safety, and pharmacokinetics (PK) of moroctocog alfa (AF-CC) in previously treated subjects, who are younger than 6 years of age, with severe or moderately severe hemophilia A.
What is the current status of trial NCT00543439?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 66 participants. The study started on 2007-12. Estimated completion is 2018-04.
What interventions are being tested in trial NCT00543439?
The interventions under investigation include: Moroctocog alfa (AF-CC) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00543439?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00543439's enrollment target sits among peer trials
66 1797th of 2000 higher than 204 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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